MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	102954
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.Reporter postal office or zip code: (b)(6).
Event or Problem Description
It was reported that the centrimag (cmag) stopped while it was on extracorporeal membrane oxygenation (ecmo) and displayed motor failure error message.The motor and backup console were switched out.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of an atypical system stop with a ¿motor failure¿ error was not confirmed.The primary centrimag console was not returned for analysis, and the console in use at the time of the reported event was unable to be determined per additional information.The returned centrimag motor was also found to have performed as intended throughout testing.The root cause of the reported event was unable to be conclusively determined through this analysis.Section 10, entitled "emergency/trouble shooting" of the centrimag primary console operating manual, states: "the recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the centrimag primary console operating manual (¿console alarm/alert strategy¿) instructs users on how to resolve alarms that sound from the primary centrimag console and what steps to take in situations where alarms cannot resolve.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was stated that the patient was stable through changeout process.Motor: mfr # 3003306248-2022-14508.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15753238
• Report Number: 3003306248-2022-14509
• Device Sequence Number: 19579121
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: 7640135140672
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 93 KG